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Behavioral Intervention

Arm 2 - Intervention for Swallowing Difficulty (ESSI-SURG Trial)

N/A

Recruiting

Led By Jonathan Irish, MD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Newly diagnosed patients with at least T2 stage tongue SCC who are planned for partial glossectomy and free flap reconstruction and are anticipated to achieve a post-operative independent oral intake

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to post-discharge week 5

Awards & highlights

ESSI-SURG Trial Summary

This trial will examine whether early and systematic speech and swallowing therapy with speech-language pathologists can help improve the health and function of patients with oral cavity cancer, specifically tongue cancer, who are undergoing surgery.

Who is the study for?

This trial is for newly diagnosed patients with at least T2 stage tongue cancer, scheduled for partial tongue removal and reconstruction surgery. They should be able to eat on their own after surgery and must understand English well.Check my eligibility

What is being tested?

The study tests if early intervention by speech-language pathologists (SLPs) before problems start can help head and neck cancer patients recover better post-surgery. It compares this new approach (ESSI-SURG) with the usual care given.See study design

What are the potential side effects?

Since this trial involves non-drug interventions like speech and swallowing therapy, side effects are minimal but may include discomfort or fatigue from the exercises prescribed by the SLPs.

ESSI-SURG Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am newly diagnosed with stage T2 or higher tongue cancer and will have surgery and reconstruction.

ESSI-SURG Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to post-discharge week 5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to post-discharge week 5

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to post-discharge week 5 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Study feasibility as measured by attrition

Study feasibility as measured by data fidelity for clinician assessments

Study feasibility as measured by data fidelity for patient-reported outcomes

+1 more

ESSI-SURG Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 2 - InterventionExperimental Treatment1 Intervention

Participants in this Arm will receive the ESSI-SURG behavioural intervention by a live SLP.

Group II: Arm 1 - ControlActive Control1 Intervention

Participants in this Arm will receive the current standard of care, which includes a referral to SLP in response to suspicion of a swallowing problem from either assessment by the medical team and/or patient report.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,476 Previous Clinical Trials

485,140 Total Patients Enrolled

Jonathan Irish, MDPrincipal InvestigatorUniversity Health Network, Toronto

1 Previous Clinical Trials

4 Total Patients Enrolled

Rosemary Martino, PhDPrincipal InvestigatorUniversity Health Network, Toronto

5 Previous Clinical Trials

1,725 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants currently being recruited for this ongoing study?

"Indeed, the information provided by clinicaltrials.gov indicates that this study is actively seeking individuals to participate. The trial was initially posted on December 1st, 2023 and underwent its most recent revision on December 20th, 2023. In total, the trial aims to enroll a cohort of 40 participants at one specific location."

Answered by AI

What is the upper limit on the number of individuals participating in this research endeavor?

"Indeed, according to the details provided on clinicaltrials.gov, this study is currently in the recruitment phase. It was initially posted on December 1st, 2023 and last updated on December 20th, 2023. The trial aims to enroll a total of 40 participants from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Feasibility of Early Swallowing and Speech Intervention for Head and Neck Cancer Patients Treated SURGically

Rosemary Martino, PhD 2023. "Feasibility of Early Swallowing and Speech Intervention for Head and Neck Cancer Patients Treated SURGically". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06192771.

All > Surgery